Acquiring patients for clinical trials can be a challenge. Professionals involved in clinical trial planning are conscious that customers have specific recruiting requirements and criteria that have to be met to the highest possible standards. The solution is the use of an intelligent data platform to automate the selection process and make it more accurate and tailored to expectations.
An RFP requiring country selection in Europe for a Phase IIb study in acute ischemic stroke
Introduction. What is Clinscience?
Clinscience is a global SMART CRO with a presence in 4 countries in Europe, the United States, and India. Clinscience offers industry-leading, integrated technology solutions tailored to the clients’ programs with an attentive, trusted, and solution-oriented team. Clinscience’s pledge is to support its clients in achieving their drug development goals.
Clinscience has a network of 90+ partner sites all over Europe and North America. To meet Sponsors’ needs and develop a reliable patient recruitment strategy, Clinscience collects intelligence on epidemiology, country regulations and drug reimbursements, and investigator experience.
What was the challenge?
Clinscience received an RFP for a Phase IIb study in acute ischemic stroke (AIS) seeking to enroll 500 patients in 45 sites in Europe. The client had a list of four pre-selected countries in Western Europe that were involved in the Phase Ib/IIa study of the same investigational product. The client asked Clinscience to identify one additional country in Western Europe and to identify five countries in Central/Eastern Europe.
The targeted patients for this study would have to undergo endovascular therapy (EVT) and magnetic resonance imaging (MRI), so the selected sites would have to be AIS reference sites. This criterion limited Clinscience’s access to sites via their site network. In order to identify countries and sites for this study, Clinscience relied on TrialHub’s support.
What was the approach? TrialHub algorithms in the service of clinical trials
TrialHub is a data intelligence platform that helps CROs plan clinical trials by automating calculations such as average recruitment rate (ARR), competition, and study experience, among other parameters. Additionally, TrialHub’s feasibility overview allows us to rank countries according to these criteria.
Clinscience educates our clients on the optimal global recruitment strategy from the easily-digestible data we obtain from TrialHub. – commenting Adrian Williams, Global Head of Budgets & Proposals Clinscience – We make data-driven decisions that build trust with our clients. These data-driven decisions and trusting partnerships, help our clients get their market products to patients on-budget and on-time.
TrialHub’s state-of-the-art algorithm aggregated real-time data from 80 000 sources, including all clinical trial registries, and in a few clicks provided Clinscience with a long list of sites experienced in the indication. The platform also crawled the internet in real-time to complete the set of data with the most current investigator contacts where they were missing from the registries.
Next, Clinscience turned to the expertise of TrialHub’s analysts, experienced in thousands of trials, and asked for an additional country and site assessment. Their analysis, based on the protocol synopsis and key operational factors such as sites able to administer EVT and perform MRI, provided a list of countries and helped Clinscience shortlist sites that would fulfill the study requirements and patient target for this study.
The selection of sites was based on the sites’ previous experience in the indication and with EVT procedure, the number of currently recruiting and ongoing trials, and the sites’ location.
How did this approach help?
Clinscience was able to confirm the client’s pre-selected countries and to pre-identify additional countries that would best suit the client’s needs for this particular trial in just a few clicks and get an additional level of expert analysis that supported their selection.
TrialHub’s approach to data overcomes the registries’ inaccuracies and helped Clinscience present their country and site selection with the confidence that every site with relevant experience was considered accordingly.
Clinscience is one of the few CROs that started as a site management organization in Europe. This gives them an incredible advantage when planning а clinical trial because they know firsthand precisely how to select the right trial partners. – said Maya Zlatanova, CEO of TrialHub – I am glad we have the chance to support them in replicating this model globally and to complement their experience with accurate and real-time insights on the clinical research landscape.